Medical apparatus for use by a patient for medical self treatment of diabetes

ABSTRACT

The invention relates to an apparatus for self-treatment of diabetes. The apparatus is particularly advantageous by comprising a plurality of devices each of which has its own dedicated function corresponding to a number of acts which a diabetic must perform on himself. The individual devices are mutually interconnectible, and the combination comprises at least a body fluid analyser and a dosing apparatus for administering a predetermined dose of insulin to the patient. Each of the devices may be provided in several sizes so that the user himself may combine the relevant devices of the relevant size with respect to the current need. This reduces the risk of forgetting parts of the equipment, and the confidence of using the equipment is enhanced because it is evident to the user that it is a complete apparatus consisting of unified parts.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.09/870,392, filed May 30, 2001, which is a continuation of U.S.application Ser. No. 09/312,796, filed May 17, 1999, which applicationsare incorporated by reference herein. This application also claimspriority under 35 U.S.C. § 119 of Danish application PA 1998 00714,filed May 20, 1998, and of U.S. Provisional Application No. 60/087,187,filed on May 29, 1998.

BACKGROUND OF THE INVENTION

This invention comprises a medical apparatus for use by a patient formedical self treatment of diabetes, the treatment including a firstoperation and at least a second operation, the apparatus comprising afirst device for performing the first operation and a second device forperforming the second operation.

For a number of years it has been possible to purchase various devicesfor the treatment of diabetes, e.g. for injecting insulin, for measuringblood sugar (such a device is referred to as BGM below), for withdrawingblood samples, and other accessories, the purpose of which is to enablethe patient to nurse his disease discretely and with a high standard ofhygiene. Many diabetic patients are elderly people who can easily getinsecure with respect to the medical equipment, but also many youngpeople need to assure themselves that the equipment is in order, i.e.that everything is there. Or as one must often say to one's children:You have got it all, haven't you?

It has also been attempted to build several of the necessary devicestogether to a single integral unit, see e.g. U.S. Pat. No. 5,536,249.This is not the ideal solution either, because such multi-functionaldevices are normally difficult to operate. A patient holding a gadget inhis hand may not be entirely secure and convinced that he has set theapparatus to precisely the function to be performed by means ofprogrammable computers. The more complicated an apparatus, the greaterthe risk of malfunction, meaning that two such multi-functional devicesshould actually be at disposal.

The individual devices may be arranged for various respective functionsrelevant to the treatment of diabetes, such as: a lancet device, a bodyfluid analyser, a dosing apparatus for administering a predetermineddose of medication to the patient. Further, there is a number of otheraids which the diabetic patient uses, e.g. test strips for the bloodanalyser, napkins for wiping off blood, extra insulin carpoule, glucosetablets, waste containers, etc.

It is not common to build two individual devices together, asmanufacturers within the field have tended to specialize in a singledevice. However, U.S. Pat. No. 4,469,110 discloses a lancet device and asimple form of BGM (the calorimetric measuring principle) which may bemutually interconnected to a single portable unit.

BRIEF SUMMARY OF THE INVENTION

The object of the invention is to make the individual devices physicallyinterconnectible with a view to optimizing self-treatment of diabetes.

Another object is to construct the individual interconnectible devicessuch that the optimum treatment is as independent as possible of thespecific situation of the user.

A further object of the invention is to provide an apparatus of thepresent type for self-treatment of diseases, where, on one hand, theuser is certain that he has all the devices which will be relevant for afuture span of time, and on the other hand, is confident about the useof the apparatus.

The object is achieved by making at least a BGM and an insulin doserinterconnectible to a single device. Precisely this combination promotesthe insulin treatment, as it will be more obvious to the user to adjustthe insulin balance if he has just measured his blood sugar; or if theuser knows that he is soon to take insulin, it will be more obvious tocheck the blood sugar content first. This combination departs from thecommon view where these two devices do not belong together, presumablybecause the manufacturers have specialized within either the one or theother device.

The invention is not restricted to the combination of BGM and insulindoser devices, as these devices may be coupled with other devices whichare used in the insulin treatment.

The fact that the individual devices may be combined so that theapparatus covers precisely a given need, means that the apparatus takesup as little space is possible, it being simultaneously easy, even forvisually handicapped users, to identify each individual device, so thatthey will be quite confident that the units fit together. When thedevices fit together physically, the users will also be confident thatthe e.g. the measuring units used are the same. This improves theconfidence of using the apparatus of the invention.

A blood sugar measuring device normally comprises a temperaturemonitoring device, and in a preferred embodiment the latter device isarranged such that it is close to the insulin carpoule when the bloodfluid analyser and the insulin injecting device are coupled togetheraccording to the invention. The temperature monitoring device may herebybe used not only for adjusting the blood sugar measurement, but may alsobe used to warn the user if the apparatus has been in a too hotenvironment and the insulin has been destroyed. This is a particulartechnical advantage by combining precisely the BGM and the doser.

In addition to the possibility of coupling various devices together asneeded, it is also possible for one or more of the devices to haveseveral sizes. This may be relevant particularly for the insulininjecting device and for a storage device, enabling the user to combineprecisely the devices of the relevant size which will be needed in agiven situation, such as an evening party, a working day,. a weekend oron a holiday. The optimum treatment achieved by the apparatus of theinvention is hereby more independent of the specific situations in whichthe user may be, and in which the treatment would be inconvenient withthe known separate devices.

In the invention, the devices have their own easily recognisablefunctions which are well-known to the user. The invention does notexclude the use of others of the user's older (i.e. well-known andsecure) devices in combination with the invention, which, however,inspires the user to extend his self-treatment apparatus with unitswhich fit together according to the invention.

Conclusively, it is an essential feature of the invention that thestated advantages are of great importance to the user's perception ofand habituation to regarding BGM measurement and insulin dosing asclosely unified actions, which results in a better self-treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a prior art doser with a conventional cap.

FIG. 2 shows a doser and a cap with a BGM attached.

FIG. 3 shows a doser and a cap with a BGM and a lancet device attached.

FIG. 4 shows a doser and a cap with a BGM, a lancet device and acontainer for test strips attached.

FIG. 5 shows a cap with a BGM, a lancet device, a test strip containerand an additional container together with useful/needed extras.

FIG. 6 shows a cap with BGM, a lancet device, a test strip container anda mini-doser and a half-size container together with useful/neededextras.

FIG. 7 shows a first combination of the items presented in FIGS. 1-6.

FIG. 8 shows a second combination of the items presented in FIGS. 1-6.

FIG. 9 shows a third combination of the items presented in FIGS. 1-6.

DETAILED DESCRIPTION OF THE INVENTION

In the following an embodiment of the invention will be described indetail with reference to FIGS. 1-6. FIGS. 7-11 show some usefulcombinations which illustrate the use of the invention.

The invention also opens up the possibility of a wide variety ofcombinations as each of said devices may be provided in several sizes.The preferred insulin dosing device may e.g. be replaced by two insulininjection pens of half the size, and a waste container may be insertedinstead of one of these pens.

FIG. 1 shows a doser 20 and a cap 10. The doser 20 comprises a turningwheel 21 for adjusting, either electronically or manually, thelevel/amount of medication to be administered, and a display 22 thatshows the currently selected amount of medication to be administered.The doser 20 has processing means and storage facilities, like a CPU andRAM, for storing data, like the time, date and amount of medication ofthe last couple of administrations. This information can be shown in thedisplay 22 at request. The doser 20 further comprises a carpoule (notshown) that contains the medication, and is fitted with a needle 27through which the medication is administered. The doser 20 has atransparent window 25 so that the amount of medication left in thecarpoule can readily be identified. The cap 10 can be fitted to thedoser 20 so that one single compact unit and protection of the doser 20,needle 27, etc. is obtained.

FIG. 2 shows a doser 20 which corresponds to the doser in FIG. 1. Alsoshown is a cap part 10, and a BGM 30. The invention is based on thecircumstance that the doser 20 and the BGM 30 should be used togethervery frequently, one embodiment of the invention might be a cap wherethe BGM 30 is an integral part. Another embodiment, which is the oneshown in FIG. 2 and described later, could be one where the BGM 30 canbe fitted removable by the locking means 31 to the cap part 10 in such away that a single unit 35 serving as a cap is formed. This has theadvantage that when the cap unit 35 is fitted to the doser 20, one setof parts associated functionally can be obtained in a very compact andconvenient form. Another option available to the user by thisarrangement is that if in special cases the BGM 30 is not needed in agiven situation, the user can simply leave the BGM 30 at home, therebyreducing and keeping the size of the device to an absolute minimum.

The BGM 30 has means 34 for inserting test strips 52 (not shown, seeFIG. 4) containing a sample of blood, for analysis by the BGM 30 byoperating the buttons 36. The result of the analysis is shown in thedisplay 32.

The cap unit 35 may also be provided with a temperature sensor 12, whichdetermines the outside temperature during operation of the BGM 30. Thistemperature is needed for the calibration of the BGM 30 prior to theanalysis of a blood sample. The temperature. sensor 12 could be placedclose to the carpoule, so that an additional benefit, apart from beingused in the calibration, is achieved when the cap unit 35 is fitted overthe doser 20. In this location the sensor 12 can monitor the temperatureof the medication contained inside the carpoule. This additional featureis very convenient if the medication is sensitive to temperature andcould be ruined or damaged if the temperature of the medication isoutside a given interval. Thus the BGM 30 could notify the user if themedication has been exposed to a harmful temperature, which improves theuser's safety, especially in the case of the medication being insulin,where the consumption/injection of damaged medicine could causelife-threatening situations.

FIG. 3 shows a doser 20 and a cap unit 35, preferably comprising the cap10 and the BGM 30, like the cap unit in FIG. 2, but with the additionalfeature of having a lancet device 40 removably attached to the BGM 30 bythe locking means 31. This lancet device 40 is used by first loading thelancet device through the grip 44 and then pressing the button 42, whichreleases the lancet, piercing the skin, so that a blood sample can beobtained. With this inclusion the lancet device 40 is always at hand.This has the advantage that a lancet device 40 always is available, fortaking a blood sample and applying it to a test strip 52. The test-strip52 can then be inserted via the means 34 into the BGM 30, which willstart analysing the blood sample and, after completion of the analysis,will show the result in the display 32. It is very useful to have theBGM 30 and the lancet device 40 attached together in one compact unit,since a BGM 30 would not normally be used without the lancet device 40,thereby avoiding the fuss and uncertainty of using multiple devices ofperhaps different makes. On the other hand, if the user already has alancet device and is accustomed to and familiar with the use of thisparticular lancet device, he can still use this original lancet deviceand just use the remaining items, which will be a compact set consistingof a doser 20 and a BGM 30; The cost will be reduced hereby.

FIG. 4 shows a doser 20 and a cap unit 35 from FIG. 3, but where theadditional feature of a test strip container 50 for the safekeeping/storing of test-strips 52 in the space 55 can be added/attachedthrough locking means 31. With this addition a test strip 52 will alwaysbe available. This addition further strengthens the use of the compactunit obtained, when the cap unit 35 is fitted to the doser 20. Now theuser can either have a single compact unit where all the means fortaking and analysing a blood sample are available, or have an evensmaller compact unit with just the items (e.g. doser 20 with a BGM 30plus either a test strip container 50 or a lancet) that are needed,depending on the specific situation.

FIG. 4 shows one of the many possible combinations which may be achievedwith the apparatus according to the invention. Other examples ofexpedient combinations are shown in FIGS. 7-9. The combination shown inFIG. 4 has the general advantage that it may induce the user to makesome additional blood sugar measurements and possibly regulate withinsulin injection when the parts are in an assembled state as one unit.There are also situations in which many blood sugar measurements andinjections are required, viz. in connection with so-called insulinanalogs which are very rapid action substances, within the order of 10minutes.

FIG. 5 shows a cap unit 35 that corresponds to the cap unit in FIG. 4.Instead of having a doser 20, there is now provided a container unit 60with a relative large space 69 for storing the items needed everyday forself-treatment. For a diabetic, e.g. such items could be a napkin 61 forwiping excessive blood after a sample has been taken, a waste container62 for receiving used items, an extra carpoule 63 which could containanother type of insulin, spare needles 27 for the doser, spare lancets65 for the lancet device 40, some glucose in the form of glucose tablets64, etc. In some situations and in certain forms of diabetes, theinjection of insulin may be replaced by administration of pills whichmay be stored in the container, which thus replaces the doser describedpreviously. All these items, or the most relevant ones for a givensituation, could be held in the container space 69 for easy retrieval,when needed. Previously the user had to carry a bag for each device(BGM, doser, lancet device, etc.) with the respective accessories. Sowhen the cap unit 35 is fitted to the container unit 60, a singlecompact, easily portable unit is obtained, which can be customised tomeet an individual need for an individual day or situation.

Of course, the individual devices may also be interconnected without theBMG and the doser being coupled together according to the invention. Ifthe doser 20 is not needed—a diabetic does not always need a doser inall situations, since sometimes he only need to observe the glucoselevel in his blood and regulate this level through a diet—one compactunit with all necessary items readily available is obtained. If a doser20 is needed, the doser 20 may be fitted with an ordinary cap 10, andthus there will just be two units that contain everything needed inevery situation in a very compact and convenient form.

FIG. 6 shows a cap unit 35 and extras 61-65 and 27 corresponding to theunit and extras in FIG. 5. Also shown is a simple small-sized (e.g.disposable) doser 80 (e.g. an insulin injecting pen) with a turningwheel 85 for adjusting the level/amount of medication to beadministered. During the adjustment, a display 84 shows the currentlyselected amount of medication to be administered. After the appropriatelevel of medication has been set, the user can press the release button82, which manually injects/administers the selected amount of medicationthrough the needle 87. The doser 80 further comprises a carpoule (notshown) that contains the medication. The doser 80 has a transparentwindow 88, so that the amount of medication left in the carpoule readilycan be identified. This embodiment also includes a container unit 70,which is half the size of the container unit 60 in FIG. 5. These smallsize units 70, 80 can be fitted into the cap unit 35 so thereby formingone compact self-treatment unit.

So with this set of modules an optimal compact set can be customisedwith the things needed for a given situation. The set can either beconfigured to meet a situation where all the items are needed, thusending up with two compact units, namely the doser 20 with an ordinarycap 10 and a cap unit 35 with the large container 60 that contains someor all of the extras 61-65 and 27, or be configured to a minimal setcontaining just items needed for one single situation, e.g. the smalldoser 80, the half-size container 70 fitted into the cap unit 35with/without the BGM 30, the lancet device 40 and the test stripcontainer 50, depending on the specific situation.

FIG. 7 shows a combination of the cap 10, the BMG 30 and the storagecontainer 60. Such a combination of devices is relevant e.g. inconnection with type 2 diabetics who may take insulin regulatingmedication in tablet form. Here, the storage container 60 may containspare lancets 65 (which may belong to another make of lancet devices,which are not shown in the combination in FIG. 7), test strips 52,glucose in the form of glucose tablets 64 and the insulin regulatingmedication in tablet form. Another use of the combination shown in FIG.7 is non-refrigerated storage of extra insulin, the temperature thenbeing monitored by the temperature monitoring device 12.

The combination shown in FIG. 8 might be called all in one. The insulininjecting device is replaced by an insulin injecting pen of half thesize, which gives room for a container 70 (half as large as thecontainer 60 in FIG. 7).

FIG. 9 shows another possible combination, using two insulin injectingpens so that the user may carry rapid action insulin as well as slowaction insulin. One of the pens may also contain one of the very rapidaction insulin analogs mentioned above. Clearly, the combination in FIG.9 may also be supplemented with a lancet device as shown in FIG. 8.

It will now be appreciated that there are many possible combinationswhich allow the user to combine precisely the equipment he needs in agiven situation. In the preferred embodiments, the individual devicesare combined side by side, and the storage container and the insulininjecting device are shown in the lateral direction in larger or smallerembodiments. Clearly, an apparatus according to the invention may alsocomprise devices which may be interconnected and varied in thelongitudinal direction.

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 10. (canceled) 11.A diagnostic and medication delivery system, said system comprising: ahousing; a monitor integrally disposed in the housing for monitoring acharacteristic of a sample of a bodily fluid; a medication delivery penremovably mounted in said housing; and a lancer removably mounted insaid housing, wherein said monitor is not integrally attached to saidmedication delivery pen, such that a user is provided with theflexibility to use different medication delivery pens with said systembut only one monitor.
 12. The system of claim 11 wherein the monitor isintegrated into the housing so that the housing and monitor form asingle operable unit.
 13. The system of claim 11 wherein the monitor isremovably mounted to said housing.
 14. The system of claim 12 whereinsaid housing has a first compartment adapted to receive and store themedication delivery pen and a second compartment adapted to receive andstore the lancer.
 15. The system of claim 12 wherein said first andsecond compartments are integrally formed with and embedded in saidhousing.
 16. The system of claim 12 wherein said monitor includes a teststrip interface for receiving a test strip on which the fluid sample islocated.
 17. The system of claim 12 wherein the medication delivery penis an electronic pen.
 18. The system of claim 15 wherein the medicationdelivery pen is an electronic pen.
 19. The system of claim 24 whereinsaid monitor includes a display for displaying blood glucose levels. 20.The system of claim 12 wherein said housing further includes a thirdcompartment adapted to store ancillary items including test strips. 21.The system of claim 20 wherein said third compartment includes a coverfor securing the ancillary items therein.
 22. The system of claim 14wherein said housing has first and second opposing ends and said firstand second compartments are located proximate to different ones of thefirst and second ends.
 23. The system of claim 12 wherein the medicationdelivery pen is a mechanical pen.
 24. In a diagnostic and medicationdelivery system, a unit comprising: a housing, said housing having afirst compartment adapted to removably receive and store a medicationdelivery pen and a second compartment adapted to removably receive andstore a lancer; and a monitor integrated in the housing for monitoring acharacteristic of a sample of a bodily fluid, wherein said monitor isnot integrally attached to said medication delivery pen, such that auser is provided with the flexibility to use different medicationdelivery pens with said system but only one monitor.
 25. The unit ofclaim 24 wherein said first and second compartments are integrallyformed with and embedded in said housing.
 26. The unit of claim 24wherein said monitor includes a test strip interface for receiving atest strip on which the fluid sample is located.
 27. The unit of claim24 wherein said housing further includes a third compartment adapted tostore ancillary items including test strips.
 28. The unit of claim 24wherein said housing further includes a third compartment adapted tostore ancillary items including a desiccant.
 29. The unit of claim 28wherein said third compartment includes a cover for securing theancillary items therein.
 30. The unit of claim 24 wherein said housinghas first and second opposing ends and said first and secondcompartments are located proximate to different ones of the first andsecond ends.
 31. A diagnostic and medication delivery system, saidsystem comprising: a housing; a monitor integrally disposed in thehousing for monitoring a characteristic of a sample of a bodily fluid; amedication delivery pen removably mounted in said housing; and a lancerremovably secured to said housing, wherein said monitor is notintegrally attached to said medication delivery pen, such that a user isprovided with the flexibility to use different medication delivery penswith said system but only one monitor.